Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00113529

Purpose

To assess the maximum tolerated dose and overall safety and tolerability of SU011248 administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Gefitinib + SU011248	Phase I Phase II

Drug Information available for: Sunitinib Sunitinib malate ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma

Further study details as provided by Pfizer:

Primary Outcome Measures:

Objective response rate (ORR) according to RECIST [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response (DR) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
Progression-free survival (PFS) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
One-year survival rate [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Gefitinib + SU011248 250 mg orally daily until progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed renal cell carcinoma with metastases
Evidence of unidimensionally measurable disease
Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

Exclusion Criteria:

RCC without any clear (conventional) cell component
History of or known brain metastases
Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113529

Locations

United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111-2497

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181038
Study First Received:	June 8, 2005
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00113529
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Gefitinib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009